Effects of Recruitment Maneuver on Functional Residual Capacity
Comparing Effects of Recruitment Maneuver on Functional Residual Capacity in Patients Undergo Laparoscopic Surgery : A Randomized Prospective Study.
1 other identifier
interventional
50
1 country
2
Brief Summary
Recruitment maneuver is frequently used in daily anaesthesia routine to prevent athelectasia and ventilation perfusion mismatch. Especially pneumoperitoneum in laparoscopic surgeries affects the functional residual capacity (FRC) negatively. Recently, FRC can be measured at bedside in intensive care units. The lack of studies evaluating FRC measurements peroperatively and how recruitment maneuvers affect it, attract attention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2019
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2019
CompletedFirst Posted
Study publicly available on registry
December 23, 2019
CompletedStudy Start
First participant enrolled
December 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedJune 9, 2020
June 1, 2020
4 months
December 16, 2019
June 7, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Comparison of FRC measurements at beginning and end of anesthesia
First FRC will be measured after ; the last FRC will be measure bedore the extubation
within max 5 minutes after the intubation and with max 5 minutes before the extubation
Secondary Outcomes (1)
Positive room air test
in recovery room 30 minutes after operation
Study Arms (2)
control group
NO INTERVENTION3 FRC measurements will be perforemed, whereby : First measurement; after aneshesia induction and intubation. Second measurement; after pneumoperitoneum Third measurement; end of the operation After the operation,Postoperative Room Air Test (RAT) will be applied.
study group
EXPERIMENTAL5 FRC measurements will be performed We will apply recruitment maneuver two times to patients with 30cmH2O pressure for 15 seconds . First Recruitment maneuver will be applied after the fşrst measurement of FRC following intubation Second Recuitment maneuver will be applied at the end of operation First FRC measurement after anesthesia induction and intubation. Second FRC measurement after first recruitment maneuver Third FRC measurement; after pneumoperitoneum Fourth FRC measurement before second recruitment maneuver Fifth FRC measurement after second recruitment maneuver and at the end of operation
Interventions
Eligibility Criteria
You may qualify if:
- years age 2-no lung disease 3-laparoscopic cholecystectomies surgery
You may not qualify if:
- \<18 years old
- \>65 years old
- denial of patient
- patients having one of: lung disease, cardiac failure, severe cardiac valvular disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Istanbul University
Istanbul, 34069, Turkey (Türkiye)
Istanbul University, Department of Anesthesiology
Istanbul, 34093, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elif Aygun, MD
Istanbul University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.Dr.
Study Record Dates
First Submitted
December 16, 2019
First Posted
December 23, 2019
Study Start
December 23, 2019
Primary Completion
May 1, 2020
Study Completion
June 1, 2020
Last Updated
June 9, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share